Latest News in the pharma Industry
Policy & Regulation

FDA grants Orphan Drug Designation for True North Therapeutics' lead product candidate, TNT009
13 Oct 2016
TNT009 is currently in clinical development for the treatment of autoimmune hemolytic anemia, including Cold Agglutinin Disease (CAD), a form of autoimmune hemolytic anemia.
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Arch Biopartners receives patent for Metablok
11 Oct 2016
Is the first patent issued protecting the composition and method of use for Metablok, the company's drug candidate targeting inflammation, sepsis and cancer metastasis.
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FDA accepts sNDA for Avycaz
11 Oct 2016
Application seeks to expand Avycaz label to include Phase III clinical data for the treatment of complicated urinary tract infections.
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FDA approvs infant-specific dose of Pertzye delayed-release capsules to treat EPI due to cystic fibrosis
11 Oct 2016
The new formulation will be offered in 4,000 lipase units capsule.
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Patent trial and appeal board upholds the validity of Lialda patent
6 Oct 2016
Shire pleased with the decision and will continue to vigorously defend its patents.
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Theratechnologies to move forward with development of new single vial formulation for Egrifta
28 Sep 2016
The introduction of a single vial presentation was part of commitments required by the FDA when it approved Egrifta (Tesamorelin for Injection).
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Biogen completes rolling submission of NDA to FDA for nusinersen as a treatment for spinal muscular atrophy
27 Sep 2016
Submission of Marketing Authorization Application to the EMA planned in the coming weeks.
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FDA approves Amgen's new biosimilar for multiple inflammatory diseases
25 Sep 2016
Amjevita is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases.
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Novartis receives three new FDA approvals for the expanded use of Ilaris
23 Sep 2016
Ilaris is the first and only US FDA-approved biologic treatment for patients with TRAPS, HIDS/MKD and FMF disease.
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FDA issues draft guidance on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
22 Sep 2016
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EMA validates BMS’s type II variation application for Opdivo in advanced form of bladder cancer
20 Sep 2016
Extends the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
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FDA grants accelerated approval to first drug for Duchenne muscular dystrophy
19 Sep 2016
Approval given to EXONDYS 51 (eteplirsen) as a once weekly intravenous infusion of 30 mg/kg for the treatment of DMD in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping.
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